Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
NCT ID: NCT06549335
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2024-12-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Induction therapy:
The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles.
Dosage:
1. Zanubrutinib, 160 mg bid, po, day 1-28;
2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6);
3. Lenalidomide, 25 mg qd, po, day 2-11.
Maintenance therapy:
1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years;
2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.
Interventions
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Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Induction therapy:
The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles.
Dosage:
1. Zanubrutinib, 160 mg bid, po, day 1-28;
2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6);
3. Lenalidomide, 25 mg qd, po, day 2-11.
Maintenance therapy:
1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years;
2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.
Eligibility Criteria
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Inclusion Criteria
2. Treatment naive
3. Age ≥ 18 years
4. Indications for treatment confirmed
5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
6. Must has measurable lesion in CT or PET-CT prior to treatment
7. Considered suitable for ZGR regimens
8. Informed consented
Exclusion Criteria
* HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
* Any drug contraindication in the treatment plan
* Pregnant or lactating women
* Patients judged by other researchers to be unsuitable for inclusion in the study
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director, Hematology Department
Locations
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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FL-ZGR
Identifier Type: -
Identifier Source: org_study_id
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